Patient Safety and Quality
Improvement
What, Why and How Can We Teach It?
ACGME Requirements…
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Practice-based Learning and Improvement: Residents must demonstrate the ability to
investigate and evaluate their care of patients, to appraise and assimilate scientific
evidence, and to continuously improve patient care based on constant self-evaluation
and life-long learning.
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identify strengths, deficiencies, and limits in one’s knowledge and expertise;
set learning and improvement goals;
identify and perform appropriate learning activities;
systematically analyze practice using quality improvement methods, and implement changes with
the goal of practice improvement;
incorporate formative evaluation feedback into daily practice;
locate, appraise, and assimilate evidence from scientific studies related to their patients’ health problems;
use information technology to optimize learning;
participate in the education of patients, families, students, residents and other health professionals.
Systems-based Practice: Residents must demonstrate an awareness of and
responsiveness to the larger context and system of health care, as well as the ability
to call effectively on other resources in the system to provide optimal health care.
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work effectively in various health care delivery settings and systems relevant to their clinical specialty;
coordinate patient care within the health care system relevant to their clinical specialty;
incorporate considerations of cost awareness and risk-benefit analysis in patient and/or populationbased care as appropriate;
advocate for quality patient care and optimal patient care systems;
work in interprofessional teams to enhance patient safety and improve patient care quality; ‘
participate in identifying system errors and implementing potential systems solutions.
So far, what do we have?
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Teachers
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VA Chief Resident(s) for Patient Safety and Quality Improvement
Hospitalists (VA) including Assistant Chief for Patient Safety and
QI
Primary Care (VA, USF and 30th St)
Simulation Center
Dr Fabri
Learners
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Internal Medicine Residents- elective and ward months,
outpatient block
Medical Students- 3rd year internal medicine rotation, 4th year
elective, AI
Occupational Medicine Residents
VA Nursing Staff
Outline
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Patient Safety Principles/Activities
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Quality Improvement Tools
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Flow Chart
Fishbone
Plan-Do-Study-Act
Quality Improvement Initiatives
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Swiss Cheese Model
Root Cause Analyses
Human Factors Engineering
Examples of Plan-Do-Study-Act Cycles
Conclusion
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Logistics
Goals for the Future
Resources
Highly publicized Errors in MedicineNormal Accidents?
Error
Institution
Year
Impact
Libby Zion 18 yo
woman dies of a
medical mistake, partly
due to lax resident
supervision
Cornell’s NY Hospital
1984
Public discussion
regarding resident
training-> work hour
regulations
Betsy Lehman, a Boston
Globe healthcare
reporter, dies of a
chemotherapy overdose
Harvard’s Dana Farber
Cancer Institute
1994
New focus on med
errors, computerized
prescribing
Willie King, a 51 yo
diabetic, has the wrong
leg amputated
University Community
Hospital, Tampa
1995
New focus on wrong-site
surgery, Joint
commissions’s universal
protocol
18 month old Josie King
dies of dehydration
Johns Hopkins
2001
Josie’s parents form an
alliance with Hopkin’s
leadership
Jessica Santillan, a 17
yo from Mexico, dies
after receiving a heart
lung transplant of the
wrong blood type
Duke
2003
New focus on errors in
transplantation and on
enforcing strick high
reliability protocols for
communication of crucial
data
Wachter, R. M. (2008). Understanding patient safety. New York, McGraw-Hill Medical.
Patient Safety
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1991- Harvard Medical Practice Study, NEJM
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Reviewed >30,000 medical charts
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Adverse event was defined as: “injury that was caused by medical
management (rather than the underlying disease) and that prolonged
the hospitalization, produced a disability at the time of discharge or
both.”
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4% of admissions were injured
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13.6% of these adverse events led to death
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>50% were preventable (although lots of disagreement on this)
Brennan, T. A., L. L. Leape, et al. (1991). "Incidence of adverse events and negligence in hospitalized
patients. Results of the Harvard Medical Practice Study I." N Engl J Med 324(6): 370-376.
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1999/2000- Institute of Medicine report: “To Err is Human: Building a Safer
Health System”
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Estimated 44,000-98,000 Americans die each year from medical
mistakes
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50% of these deaths were counted as “not preventable”
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Deaths due to preventable adverse events were greater than MVA,
breast cancer or AIDS
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Equal to a jumbo jet crashing every day
Kohn, L. T., J. Corrigan, et al. (2000). To err is human : building a safer health system. Washington,
D.C., National Academy Press.
Patient Safety Principles and
Activities
 Swiss
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Tracers
 Root
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Cheese Model
Cause Analyses
Mock- RCA
 Human
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Factors Engineering
HFE workshops
Swiss Cheese Model
• Need to focus on the “root causes” not just the sharp end of the error
Culture of Low
Expectations
No procedural
ID protocol
Production
Pressures
Steep Authority
Gradients
Reason, J. T. (1990). Human error. Cambridge England ; New York, Cambridge University Press.
Activity: Tracers
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Examine common hospital
processes with high
impact on patient safety
and quality of care,
identify vulnerabilities and
safeguards
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MRI Tracer
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Pharmacy Tracer
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Thoracentesis Tracer
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GI consult Tracer
1.
2.
Identify “layers of
cheese”
Identify “holes in the
cheese”
How do we analyze these
adverse events?
 Root
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Cause Analyses
What happened, why did it happen, what can
be done?
Triggered from actual events and close calls
with “severe” potential
Activity: Mock RCA
4 Basic Steps in an RCA
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1) Identify the Problem
2) Event Flow Chart
3) Cause and Effect Diagram
4) Develop Solutions or “Actions”
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Strong- architectural/physical plant changes, new devise,
engineering control or interlock, remove unnecessary steps
Intermediate- increase staffing/decrease in workload, software
enhancement modifications, checklists
Weak- double checks, warning and labels, new procedure
memorandum, training
What is Human Factors Engineering?
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Designing systems devices, software and tools to fit
human capabilities and limitations
 Minimize error and optimize safety
Using established methods to gather unique information
about
 Hidden needs of the end-user
 Unexpected interactions between the system and the
user
Taking advantage of knowledge bases about human
system interaction
Human Factors Engineering
VS.
“ At one point, the pulmonologist tried to put a mask over [Steve Jobs] face when he
was deeply sedated. Jobs ripped it off and mumbled that he hated the design and
refused to wear it. Though barely able to speak, he ordered them to bring five
different options for the mask and he would pick a design he liked…He also hated the
oxygen monitor they put on his fingers. He told them it was ugly and too complex.”
- New Yorker, Nov 14th
Activity: HFE Workshop
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Identify and understand how
human strengths and
weaknesses affect system
design, interact with the
environment and contribute
to errors
- Glucometer
- Insulin Pen
- Spiriva
- Thoracentesis Kit
- Venti-masks
- Suction on code cart
- Ideas?
 Identify
weak/intermediate/strong
actions
Make sure to use the correct color
Adaptor!?
Better
Epidemiology of Quality Problems
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1987: Wennberg et al compared New Haven and
Boston university hospitals
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In 1982 expenditures per head for inpatient care were
$451 in New haven and $889 in Boston
Found widespread deviations from best practices
Wennberg, J. E., J. L. Freeman, et al. (1987). "Are hospital services rationed in New Haven or over-utilised in
Boston?" Lancet 1(8543): 1185-1189.
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Many studies since have demonstrated large
variations in quality of care based on race, income and
gender (“ healthcare disparities”)
 2003: McGlynn et al evaluated 12 metropolitan areas
in the US, looked at performance on 439 indicators of
quality of care for 30 acute and chronic conditions as
well as preventative care
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54.9% of patients received recommended care
McGlynn et al. “The Quality of Health Care Delivered to Adults in the United States.” NEJM 2003; 348: 2635-45
Question: “how can doctors and hospitals be practicing high quality,
evidence-based medicine yet have such stunningly different approaches
to the same problem?”
What is Quality?
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In 2001, IOM report: Crossing the Quality
Chasm defined 6 aims for a quality healthcare
system
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Patient safety
Patient-centeredness
Effectiveness
Efficiency
Timeliness
Equity
• Quality is not just delivery of EBM, its much broader
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Lean: Maximizing value-added processes, eliminating waste,
from the perspective of the end user (the PATIENT)
 Six Sigma: Remove defects, reduce variability
QI Tools: Process Flow Diagrams
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Graphic representation of the sequence of
steps in a process
 Often, one member of the process is not
aware of what the other members are doing
 Stay as high as possible, for as long as
possible (the Woodstock rule)
Sample Flow Chart
Scheduling
Prearrival
Front desk
Sign instructs
patient to stop at
prearrival desk
Patient makes
appointment
Nurse or MA
Yes
NPQ completed?
Obtain insurance
information
Physician
Call patient from
waiting room
Look at changes
entered by nurse in
AllScripts
Weigh, bring into
exam room, vitals
Read annotations
and questions on
paper medication
list
No
Appt. at least X
days in advance?
No
Scheduling instructs
patient to arrive 30
minutes in advance
of appointment for
completing
paperwork
Yes
Scheduling mails
New Patient
Questionnaire (NPQ)
to patient
Established
patient?
Yes
Print out patient
medication list
Instruct patient to
return to prearrival
desk
No
Ask whether patient
received and
completed NPQ
Established
patient?
Yes
Print and review
patient medication
list
Adjust as
appropriate
No
Yes
NPQ complete
No
Give NPQ to patient
and instruct to
complete form in
waiting room
Review medication
list from NPQ
1) enter definite changes into computer using
record function
2) enter over-the-counter medications using record
function
3) enter allergies
4) enter pharmacy
5) ask about refills; write “R” in the left margin
beside medications that need refills
6) write issues/questions on paper list
Print updated
medication list and
give to patient at
end of visit
What is an Ishikawa Diagram
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Developed by Ishikawa in Kawasaki Shipyards
Made famous when used in the development of the Mazda Miata
AKA Fishbone diagram
Brainstorming Tool
Tool for uncovering and describing factors that influence an
outcome
3 steps:
1.
Identify the problem
- A concise problem statement
- i.e. Long Wait times in Clinic
2. Create headers for the fish skeleton
- Need to be mutually exclusive and comprehensive
- i.e. People, Policy, Methods, Materials, Other
3. Investigate each of the headers for more concrete examples
- i.e. understaffing at the pharmacy would fall under Man Power
Fishbone Example: Long Wait
Times in Primary Care Clinic
People
Policy
HIPAA limits abilities
of front desk personel
Nursing understaffed
Each physician likes things
done differently
Allscripts communication rather
than verbal
Redundancy- pts filling out same forms
and questions multiple times
Not enough exam rooms
Too many steps in the
process- precheckin,
Outdated new patient questionnaires
checkin, nursing intake etc..
Methods
Materials
Long wait times
in walk-in clinic
Examples of PDSAs….
What changes for next cycle?
Can the change be implemented
ACT
STUDY
Complete the analysis
Compare data to predictions
Summarize what was learned
Set objective
Ask questions
Make predictions
Plan how to answer
Collect data
PLAN
DO
Carry out the plan
Collect the data
Begin analysis of the data
PLAN: Project Charter
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Problem Statement: There are discrepancies between physician MRI screening questionnaires
and MRI tech screening questionnaires
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Primary Metric: Mean # of discrepancies per chart
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Project Goals/Objectives: Reduce mean # of discrepancies per chart by 70% and increase the
likelihood of a single chart making it through the process without a discrepancy
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Scope: Inpatients receiving MRIs Monday-Friday
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Team
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Champion: Dr. Lezama
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Process Owner: Dr. Joseph Parise
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Members: Dr. Emily Lorch, Dr. Alex Reiss (Hospitalist Chief) Carolyn Eubanks (MRI tech
supervisor), Gwen Patterson (MRI tech), MRI clerk, Lynn Martinez (CPRS)
What is the impact to:
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Customers: improved MRI safety, decreased # of redundant forms
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Company: improved MRI safety, improved efficiency
PLAN: Process Mapping
Process Level 1
MD orders MRI
MD fills out
questionnaire
MD order/
questionnaire
prints out at MRI
clerk station
MRI tech #1 fills
out questionnaire
Tech calls nurse for
quick screening
Process Level 2
Order
placed
Pop-up with
questionnai
re
MD reads
questionnai
re on
computer
screen
MD goes to
find patient
MD
questions
patient
MD reviews
chart
MD goes
back to
computer
and fills out
questionnai
re
MRI tech #2
reviews both
questionnaires
PLAN: Fishbone Diagram
Methods
Possible to bypass form
People
Staffing issues- not enough
techs
Lack of knowledge
Not windows compatible
Not enough computers
Too many questions
Not available in paper
form
Materials
Least experienced on the team
Redundancy
Pt sedated by the time they get to
MRI
Limited resident hours
Policy
Discrepancies
between
MRI forms
PLAN: 35% of the MRI forms
had at least 1 discrepancy….
80% of the defects are in 6 fields: welding, joint, back/joint surgery, contrast allergy,
Kidney or liver disease, stents
DO: Old Form
DO: New Form
DO: Educational Component
C
A
N
C
E
L
Cochlear implant
Aneurysm clip
iNfusion pump
Cardiac pacemaker
Eye metal
Limb prosthesis
M
R
I
Morbid obesity
Renal insufficiency
Insane
STUDY: Binomial Analysis
 Prior
to the changes 35% of charts had at
least 1 discrepancy between the tech form
and the MD form
 Following our interventions, 3% of the
charts had at least 1 discrepancy
Study: Fischer’s Exact
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Test and CI for Two Proportions
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Sample X N Sample p
1
35 100 0.350000
2
3 30 0.100000
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Difference = p (1) - p (2)
Estimate for difference: 0.25
95% CI for difference: (0.107649, 0.392351)
Test for difference = 0 (vs not = 0): Z = 3.44 P-Value = 0.001
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Fisher's exact test: P-Value = 0.011
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Plan for Control Chart
Week
week 1
week 2
week 3
week 4
week 5
week 6
No. of Defects No. of MRIs
2
3
4
1
2
1
100
83
90
101
80
90
Another Example of a PDSA:
Inpatient Medicine
PLAN:
Thoracentesis samples sent in wrong tube
- Trace process from inpatient medicine floors, Interventional
Radiology
- Fishbone diagram- pH and CBC were primary problems
(consistent with pareto’s law)
DO:
Modify the Medicine Order Set
STUDY: Following the intervention review what % of thoracentesis tubes were
sent incorrectly
ACT:
Educate IR about our new order set
If intervention doesn’t work, how can we modify it
Another Example of a PDSA:
Outpatient Medicine
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PLAN:
Identify a quality measure to target
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i.e. documentation of goals of care, flu shots, colonoscopy
screening
Each resident reviews their current processes and
success rate with regard to the measure
 What % of patients have appropriate documentation
 What are some barriers to meeting this measure
• May need flow diagram, fishbone, FMEA
 DO:
Develop an intervention (or action) Resident or staff education
 Make forms more available
 EMR modifications
 STUDY: Following the intervention review what % of patients have
appropriate documentation
 ACT:
If intervention works, spread the word!
If intervention doesn’t work, how can we modify it
Logistics
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Initiative needs to come from the TOP
Need to appoint a “QI/PS” team leader
Allocate time- should start with “protected time” for both
the attendings and the residents
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Suggestions:
•
•
•
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•
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Noon-conference
Morning report
Rounds
Outpatient block
Orientation
Part didactics but mostly active learning
Evaluation and feedback are important so that it seems
like a “real” part of the curriculum
Goals for the Future
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Other specialties and disciplines: surgery, OB/GYN,
psychiatry, dermatology, nursing etc..
 Teach the teacher- dry run of our SGIM workshop “A
Toolbox for Teaching Patient Safety”
 Integration into orientation for both MS III and PGY1s
 Integration into basic clinical months (rather than isolated
electives)
 Collaboration with other departments here at USF:
psychology, engineering, public health
 Collaboration with other universities
Resources
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Patient Safety
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Wachter, R. M. (2012). Understanding patient safety. New York, McGraw Hill Medical.
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Reason, J. T. (1997). Managing the risks of organizational accidents. Aldershot, Hants,
England ; Brookfield, Vt., USA, Ashgate.
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National Patient Safety Center: http://www.patientsafety.gov/curriculum/index.html (Dr.
James Bagian)
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Agency for HealthCare Research and Quality: http://webmm.ahrq.gov/
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Dr. Fabri’s Course here at USF: Patient Safety and Human Error
Quality Improvement
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Nolan, K. M. and M. W. Schall (2007). Spreading improvement across your health care
organization. Oak Brook, Ill. Cambridge, MA, Joint Commission Resources ; Institute for
Healthcare Improvement.
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Berwick, D. M., A. B. Godfrey, et al. (1990). Curing health care : new strategies for quality
improvement : a report on the National Demonstration Project on Quality Improvement in
Health Care. San Francisco, Jossey-Bass.
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Ogrinc, G., L. A. Headrick, et al. (2004). "Teaching and assessing resident competence in
practice-based learning and improvement." J Gen Intern Med 19(5 Pt 2): 496-500.
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American Society for Quality: http://asq.org/conferences/six-sigma/
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Dr. Fabri
National Meetings
SGIM- Patient Safety/QI Workshop, Precourse Orlando May 5-9th
Society for Hospitalist Medicine
Institute for HealthCare Improvement